Click column header to sort
The QA Engineer, Pharmaceutical Quality Systems (PQS) Audits & Inspections is responsible for the day-to-day activities of the Pharmaceutical Quality Systems (PQS) team. This role is primarily responsible for coordinating GMP customer audits and regulatory inspections and supporting the Quality Management Review on a local and global level.
The Associate Director (AD), Program Quality is responsible for building and sustaining the quality relationship with partners through transparent and trusting communications, working with Program Management and site SLTs to provide unprecedented delivery. This role is accountable for the quality aspects of customer programs from initial discussions through end of program review/close. The AD, Program Quality works with customers to define quality requirements and governance for all programs, and agrees the process control strategy for the program, ensuring the right level of quality at the right time and demonstrates adaptability by ensuring processes meet regulatory requirements and support...
The Sr. Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Diosynth Biotechnologies, Holly Springs (FDBN) provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FDBN Quality. The Sr. Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.
The Senior Engineer or Scientist 2 of Process Analytics serves as the subject matter expert (SME) and provides technology transfer support, technical oversight, and strategic input across laboratory and manufacturing operations. This role leads junior team members through all aspects of process analytic (PA) activities and provides technical guidance and coaching.
The QA Associate Manager (Operations DSM Upstream) leads and supervises a team of QA professionals responsible for providing day-to-day risk-based QA support of Drug Substance Manufacturing areas and processes in a fast-paced, dynamic startup environment. This role is the primary point of contact
for their team and the first-line escalation point in areas of their responsibility. This role requires collaboration with leadership, site-based customers, and
global colleagues.
Summary:
The L&D Compliance Specialist III is responsible for the design, development, and delivery of training across the FDBT Organization. They must be able to think creatively when working with Subject Matter Experts across the organization to translate complex ideas into effective training that pertains to trainee’s role and performance. Additionally, they must be...
We are hiring an IT Support Specialist. The IT Support Specialist will install, maintain, analyze, troubleshoot, and repair personal computer systems and laptops, related hardware components and computer peripherals, and personal computer software applications and operating systems. The IT Support Specialist will document, maintain, upgrade or replace hardware and software systems. They will maintain user account information including access, permissions, and systems groups, and may perform some limited system administration functions. They provide end-user technical support and training, Help Desk task management, and IT customer service.
Summary: The Manufacturing Manager, Upstream is responsible for assisting in the planning, directing, and coordinating of the activities related to the Upstream manufacturing processes while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics. The Manufacturing Manager, Upstream will oversee the cGMP production and Upstream manufacturing systems working directly with cell culture and viral propagation techniques, cell culture and bioreactor operations, bacterial and fermentation operations, pDNA, protein, and yeast related operations, and...
Summary: The Manufacturing Readiness Coordinator II assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.
The Customer Sourcing Specialist is responsible for customer onboarding activities, coordinating material enrollment, supporting tech transfer, and sourcing activities for customer programs at FDBN. Support of the Denmark facility, as needed. This role is a key link between the global sourcing organization and customer program organization for matters related to risk assessment of materials, vendors, new materials, and vendor onboarding activities. This...
The Manufacturing Technician I works directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:
The Regional Manager, Finance Business plays a pivotal role in providing financial leadership and strategic support to the commercial and program management teams within our North Carolina sites. This position requires a blend of financial expertise, business acumen, commercial mindset and the ability to influence and drive strategic initiatives. This role leads the local Finance Business Partner team in supporting all financial elements relating to revenue recognition, contract review and approval and sales to program margin forecasting. They are also responsible for ensuring financial goals are met and business strategies are effectively implemented. This role requires an experienced...
The Field Service Engineer I – US is responsible for performing scheduled service work on systems within a service area, and some unscheduled work in the service area with the assistance of technical support, as directed.
Summary:
The Assistant Scientist - Process Development is an entry level position for graduates with no prior experience or training. The individual will assist in the development and characterization of customer programs, and technology transfer to the manufacturing and/or Quality control group as appropriate. This individual will be expected to require training on laboratory instrumentation and then use instrumentation to perform elementary lab experiments and document results appropriately.
The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.
While in project phase, the schedule will be Monday-Friday during normal...
FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Mesa, AZ facility for a Purchasing Manager!
The Role
The Purchasing Manager will manage raw material commodity strategies and...
Territory Manager - Greensboro, NC - Remote
As a member of our sales team, you will sell portable ultrasound systems in a consultative, professional and high velocity sales environment. This includes creating primary market demand for FUJIFILM Sonosite products by networking, cold calling, and educating users in hospitals and the physician...
The Clinical Specialist (ARDMS Certification Required) - Minneapolis, MN position is responsible for understanding and addressing the clinical needs of customers within an assigned territory. The Clinical Specialists partner with Territory Managers to demo FUJIFILM Sonosite products, close deals, and ensure ongoing positive customer experience. After the sale, this role owns client relationships and works to encourage customer adoption and use of FUJIFILM Sonosite products.
Note: This position is open to...
Regional Sales Manager - South Central - Remote
This position is responsible for meeting the monthly, quarterly, and annual regional sales quota. Provide direction and leadership for regional sales team.
Summary: The QC Stability Coordinator III, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.
The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology,...